BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3173478 · Received June 11, 2013

    Report

    Report Number
    3006451981-2013-00181
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ABDOMINOPERINEAL PROCTECTOMY, THE DEVICE KNIFE DID NOT RETRACT AND WAS PROTRUDING FROM THE JAWS. THE SURGEON WAS WORKING ON RADIATED TISSUE THAT WAS DESCRIBED AS BEING HARD AND THICK WHEN THIS OCCURRED. WHEN REMOVING THE DEVICE, OOZING WAS NOTED BY THE SURGEON. THE AMOUNT OF OOZING WAS NOT PROVIDED BY THE CUSTOMER. THE SURGEON OPENED ANOTHER INSTRUMENT AND CONTINUED WITH THE PROCEDURE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263669 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2LF031PX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK